Comfier CF-8015 User manual

Brand
Comfier
Model
CF-8015
Type
User manual
User Manual
AS8015
TENS·EMS·MASSAGER
User manual
1
TENS and Muscle Stimulator
Model No:AS8015
Indications for Use
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in
the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to
strain from exercise or normal household work activities.
PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and
facilitate muscle performance.
Before operation, please read this user’s manual carefully, and be clear about the instructions!
Ref: 11.08.2019
User manuel
2
-22
Table of Contents:
Page
I. Foreword 3
II. Description of the Device 4
1. General Description of the Device
4
2. Definition of Contraindication, Warning and Precaution 4
2.1 Contraindication 4
2.2 Warning
4
2.3 Precaution 5
2.4 Adverse Reactions
6
3. Features 7
4. Unit description
7
5. Charging the battery 8
6. Program parameter 9
III.
User Instruction
10
Section 1 - For TENS purpose 10
1.1 Indications for Use
10
1.2 Direction for Use 10
1.2.1 Preparing the Skin for Running a Session 11
1.2.2 Regular TENS Application Principles
11
1.2.3 Regular TENS Application Methods 11
Section 2 - For PMS purpose 13
2.1 Indications for Use
13
2.2 Direction for Use 13
2.2.1 General Operation Guidance - Step by Step
13
2.2.2 Regular PMS Application Principles 13
2.2.3 Regular PMS Application Methods
14
IV. Troubleshooting 17
V. Service and Maintenance 18
1. Readjustments, alterations and repairs
18
2. Cleaning and maintenance 18
3. Storage
18
4. Technical checks 18
5. Disposal of the Unit 19
6. Warranty period
19
7. Manufacturer information 19
VI. Electromagnetic Compatibility 19
VII.
Warranty
24
manual
User manuel
3
-22
I. Foreword
Before operation, please read this user’s manual carefully, and be clear about the instructions.
Five key points for operations:
1) This device is intended for use on healthy skin.
2) The electrode pads are for single patient use.
3) Intensity is based upon your level of comfort.
4) Begin the first session with a low intensity and a short duration while learning how to operate.
5) If you feel pain, dizziness, or discomfort, call your physician.
Structure and Accessories:
Battery charger
800mm (30.5 “) long USB cable
AS-C10: lead wire type electrode cable
AS-C01: snap button type electrode
cable
Self-adhesive electrodes [K152648 & K181234]
AS-P21: 50*50mm AS-P20: 50*100mm AS-P22: 50*50mm
Included in this package:
* 1 main unit
* 8 pcs electrode pad
* 2 output electrode cables (lead wire type)
* 1 Pad holder
* 1 Touch pen
* 1 USB cable
* 1 AC charger
* 1 User’s manual
+ button
- button
On/Off button
manual
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manual
User manuel
7
-22
* Adjustable timer: 10~60 minutes
* Adjustable intensity: 20 level
* Multiple program selection: 24 programs
* Rechargeable lithium battery: DC 3.7V
* Wide voltage design: AC 100-240V 50/60Hz
4. Unit description
A. Turn on/off the Device
▲Note: Do not turn on the unit until all electrodes and lead wires are properly attached.
1) Press the On/Off button for 3s, the LCD will light up and the device will turn on. Press the On/Off button for 3s, the display
will go blank and the device will turn off.
2) The device will turn off automatically after the cure time has elapsed.
3) In an emergency you may also pull the connector(s) of electrode cable from the device to remove the electrode pads.
▲Note: To prevent unpleasant electric shocks, never remove the pads while it is still turned on.
B. Display
The touchable LCD screen displays treatment remaining time, battery power, program icons, output port, current intensity,
selected intensity and lock state. The default value of TENS and Muscle Stimulator is Program 1, Output A, Intensity 00, Timer
20min.
*Output channel
The TENS and Muscle Stimulator has 2 output channel: Channel A and Channel B. Press “A/B” button to select Output
Channel.
*Programs
The TENS and Muscle Stimulator offers in totally 24 different preset treatment programs. All parameters are pre-programmed,
except for the intensity and cure time.
Press program icons on the touchable LCD to select the program. Once you select a program, the corresponding program
number flashes per 0.5 second. The LCD display screen shows below. Note: Please refer to chapter 3 “User Instruction” to
learn how to choose the right treatment program and time.
*Intensity
Once you select a program, gradually increase the intensity by pressing the “+” button or clicking “+” icons, or decrease the
intensity by pressing the “–” button or clicking “-” icons, until you get the desired intensity level.
▲Note: If you change a program during this treatment, the intensity level will revert to the default value of “00” to protect
your safety. Channel A and channel B are independent, and you can set their intensity separately.
▲Note: You will feel the intensity increase or decrease as you select the intensity level. You can use this as a guide to select a
level that is comfortable for you. At the precondition of acceptance, the intensity should be chosen as high as possible for the
manual
User manuel
8
-22
best effect but still feel comfortable.
*Timer
Press “T” button or click timer icon to change treatment time among 10, 20, 30, 40, 50, and 60 minutes. After the time runs out,
the device will turn off automatically.
▲Note: If you change programs during the course of a therapy session, the treatment time will not reset unless you manually
reset it by performing the steps described above.
*Lock Screen
Press lock key“ ” to lock the screen, and the lock icon “ ” will appear at the top of the LCD. Press lock key“ ” again
or click lock icon “ ” to unlock the screen, and the lock icon disappears.
*Battery power
The LCD displays battery power through 4 black squares, and each square corresponds to 1/4 battery power level. When the
battery is too low, the battery icon shows “ ” and flickers, which indicates that the battery needs to be charged. During
charging, the icon runs up and down. Full bars means full battery level.
C. Connection of the electrode pads
1) The TENS and Muscle Stimulator offers 2 types of electrode cable: snap button type and lead wire type. Choose one or two
electrode cable and output ports, connect the electrode cables with socket to the output ports at the bottom of the unit.
2) Connect the snap button type electrode cables with snap button type electrode pads,and connect lead wire type electrode
cables with lead wire type electrode pads before applying them to the Skin.
3) Remove the protective plastic shields from the electrode pads before placing the pads onto your skin.
Warning: To avoid an electrical short, never put two electrode pads together.
5. Charging the Battery
1) The Lithium battery can be recharged through both AC adaptor and computer USB input.
2) When the battery is low and the LCD screen blinks, it indicates that the battery needs to charge. Turn off the unit.
3) Connect the unit and the charger with USB extension cord. Plug charger into any power outlet, the LCD shows that it is
charging and the bars in power symbol will run up and down. The charging process will last approximately 2-3 hours. When
charging is finished, the LCD will show a full battery cell.
4) The battery should be charged for 10 hours or so before first use.
Output A
Output B
manual
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manual
User manuel
16
-22
(7)
The Back (including
Trapezes or Shoulders and
Deltoids or Upper Laterals)
Follow pad placement diagram. The 2 pads from one
channel should keep 1/4 inch gap inch from each
other. The pad near the centerline, should keep 1 inch
space from the centerline of the back.
This requires 2 pair of pads.
program 17 for 10-20 minutes,
program 9 for 10-20 minutes;
Frequency: 3 to 4 times per week.
(8)
The Buttocks and Back
Thighs
Follow the placement diagram. Make sure there is
about a 1/4 inch gap between the pads. This requires
2 pair of pads for Buttocks or 2 pair of pads for Back
Thighs.
program 22 for 10-20 minutes,
program 5 for 10-20 minutes;
Frequency: 3 to 4 times per week.
(9) Back
(Alternate stimulation for
the Shoulders and Lower
Back)
Follow pad placement diagram. Draw an imaginary
line down the center of the back. Using one channel
place the pads on the left side of the centerline. Put
one pad on the top and one pad on the bottom. Now
repeat the process for the right side using the second
channel. Make sure the pads are each about one inch
from the center of the back.
program 7 for 10-20 minutes,
program 6 for 10-20 minutes;
Frequency: 3 to 4 times per week.
manual
IV. Troubleshooting
User manuel
17
-22
Problems Possible causes Try this solution
No. One pad feels stronger than the
other.
This is normal. Different areas of your
body will react differently.
Nothing needs to be done. Make sure the
pads are sticky and are making good
contact.
1 The intensity is not felt.
Very weak intensity level.
Pads are not attached to the body firmly. Attach both pads firmly to the skin.
The transparent films are still stuck to
the pads.
Peel off film on the adhesive surface of
pads.
The pads stacked together or overlap. Do not stack pads together or overlap
pads.
The cord is not properly connected to the
unit.
Connect cord correctly into the jack.
The intensity setting is getting weak. Increase the intensity level.
The battery capacity is low. Charge the battery.
2 The skin turns red or the skin
feels irritated.
The adhesive surface of pads is dirty or
dry.
Wash adhesive surface of pads softly
with your fingertips for about 3 seconds
under slow running water.
The therapy time is too long or the
intensity is set too high.
Reduce the application time or reduce
the intensity.
The electrode pad surface is worn out. Replace electrode pad.
3 No power source; no display in
LCD.
The battery capacity is depleted. Charge the battery.
4 Power cut off during use. The battery is weak. Charge the battery.
The cord is broken. Replace the cord.
5 It is difficult to attach the pad
to the skin.
Have you removed the transparent film
from the pad?
Peel off film on the adhesive surface of
pads.
Was the pad applied immediately after
washing?
Dry the pad.
Is the adhesive surface of the pad
damaged?
Replace the pad.
6 Adhesive surface of pad is not
sticky.
Are you using pad when perspiring? Use when not perspiring, in a cool room.
Were the pads stored under high
temperature, high humidity, or direct
sunshine?
Replace the pad.
manual
V. Service and Maintenance
1. Readjustments, alterations and repairs
1) Do not disassemble, repair or modify the device without authorization, you will void any warranty on the product.
User manuel
18
-22
2) The manufacturer is only responsible for the safety and performance of the TENS and Muscle Stimulator when
readjustments, alterations and repairs are carried out by authorized individuals and when the TENS and Muscle Stimulator is
used in accordance with the user instructions.
3) Qualified technicians who are familiar with the technical features of the device have been provided with circuit diagrams,
PCB drawings, component lists and setting instructions by the manufacturer.
2. Cleaning and maintenance
A. For the main unit:
1) To keep the controller clean, use a soft and dry cloth for dust or a soft damp cloth for any dirt and smudges. Do not use any
cleaning solutions to clean the controller and its pads.
2) Do not use or store the device where there are magnetic fields or electric waves (near TV set or speakers).
3) Do not place the devices in areas of high temperature, high humidity, or under direct sunlight.
4) Keep the device out of reach of children.
5) All worn accessories should be disposed of according to your local regulations.
B. For electrode pads:
* Refer to the user manual of the pads manufacturer (K152648 & K181234), or reference to the following suggestions:
1) Unplug the output cord from the output jack of the controller after each use. Cover both pads with the protective film before
storage. Never fold the electrode pads.
2) Between uses, store the electrodes in the reusable bag in a shady place. Stockroom temperature: +5°C~+27°C (41-80°F) and
humidity of 30%~80%. No need to sterilize.
3) Never apply the pads to any other surface other than your skin.
4) The life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation
site.
5) When the electrodes dry out and do not stick, buy new pads compatible with TENS and Muscle Stimulator, with smallest
area of 25cm2.
Regards buying new pads, you can contact our local device sell center, or you can contact the following electrode manufacturer,
they will tell you the local address where you can buy them. Or you can buy other 510(k) cleared electrode pads with smallest
area no less than 25cm2.
Warning: The electrodes are intended for single patient use only!
C. For Cables
1) Disconnect the cables from the stimulator and electrodes.
2) Do not pull on the cables; only pull on the connectors attached to the ends of the cables.
3) Store the stimulator with the cables in a clean, dry place.
3. Storage
Caution: Do not store in a damp area. Dampness may affect the device and cause rust.
- Normal working ambient temperature: 5°C~40°C (40-104°F)
- Normal working ambient humidity: ≤80%RH
- Store and transport ambient temperature: -20°C~55°C (4° -131° F)
- Store and transport ambient humidity: ≤93%RH
manual
4. Technical checks
Technical checks on the device should be performed every 24 months.
These include:
1) Checking to see whether the user instructions and the medical device book are included in the accompanying
documentation.
User manuel
19
-22
2) Checking the equipment for completeness.
3) Visual check:
- for mechanical damage
- for damage to all cables and connections
4) Functional safety
- Checking the output signals with a load resistance of 500Ωreal (current and voltage)
- Checking the frequency
- Checking the pulse width.
These technical checks may only be performed by individuals with appropriate training. The results must be noted in the
medical device book along with the date and name of the person carrying out the check.
5. Disposal of the Unit
To dispose of the unit, its accessories and packing materials, take appropriate actions in accordance with the rules and
regulations in force in your area to prevent adverse ecological effects.
6. Warranty period
We give a warranty of 1 year from the date of purchase on TENS and Muscle Stimulator. This warranty does not cover cables
and electrodes.
7. Manufacturer information
Shenzhen As-Tec Technology Co., Ltd.
8E XinBaoYi Industrial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012
VI. Electromagnetic Compatibility
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC and mobile (cellular) telephones, radio transceivers, mobile
radio transmitters, radio-controlled toys, and so on, Medical devices in use may be susceptible to electromagnetic interference
from other device. Electromagnetic interference may result in incorrect operation of the medical devices and create a
potentially unsafe situation. Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product
situations, the IEC 60601-1-2: 2014 standard has been implemented. This standard defines the levels of immunity to
electromagnetic interference as well as maximum levels of electromagnetic emissions for medical devices.
This unit has been thoroughly tested and inspected to assure proper performance and operation! This product needs
special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided,
the following tables recommend minimum separation distances between portable and mobile RF communications equipment
and the TENS unit.
Caution:
* The use of accessories and cables other than those specified by the manufacturer , with the
manual
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Comfier CF-8015 User manual

Brand
Comfier
Model
CF-8015
Type
User manual
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